MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION ADVANCED PERFUSION SYSTEM 1; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1

Model Number 802018

Device Problem No Audible Alarm (1019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2019

Event Type  malfunction  

Manufacturer Narrative

The field service representative (fsr) was unable to verify the reported complaint.Per the user facility, the centrifugal knob was accidentally brushed and turned below coast which they expected an alarm.Fsr explained that this was not an alarm condition.The unit operated to manufacturer's specification.Per data log analysis: 06:17:11 perfusion screen is opened.06:17:29 level is turned on.12:18:00 arterial speed lowered 1524 rpm causing a coast trigger on cpg (message only).12:38:03 arterial speed lowered to 1866 rpm.12:38:14 backflow alarm occurs.13:30:19 arterial speed quickly reduced from 2382 rpm to 1260 rpm causing another coast.There were no level event (alert or alarm) so no audio should have sounded.There was no indication of a problem in the log.

Event Description

Prior to use of the device for a cardiopulmonary bypass (cpb) procedure, the unit did not have an audible alarm for a level alert alarm.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.

Manufacturer Narrative

Updated blocks: d4 , h4 and h6.The reported issue was confirmed via log review.It was determined that the event occurred as the pump speed was accidentally moved by the end-user to coast.As a result, the flow module responded as intended.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• Brand Name: ADVANCED PERFUSION SYSTEM 1
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS-ADVANCED PERFUSION SYSTEM 1
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• MDR Report Key: 8749780
• MDR Text Key: 149685938
• Report Number: 1828100-2019-00352
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K172220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 802018
• Device Catalogue Number: 802018
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1